MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 OPTIFIX AT; STAPLE, IMPLANTABLE

Catalog Number	0113330
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was returned for evaluation.Broken fasteners were returned with the sample.Initial evaluation of the sample finds no damage in the device and the device can be fully articulated.The functional evaluation of the sample results in the deployment of the fastener without any issues.Internal component evaluation found that all the inner components in place with no anomalies found.Evaluation of the returned sample did not reproduce the reported event that the device deployed broken fasteners.Based on the sample evaluation and investigation performed, the root cause of the broken fasteners is the result of user / device interface while attempting fixation into coopers ligament as reported.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in march, 2021.The instructions-for-use supplied with the device states "care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue.Place the tip of the optifix" absorbable fixation system at the desired location perpendicular to the mesh or tissue and apply adequate counterpressure." additional precaution section of the ifu states " insertion of fasteners is possible into some collagenous structures such as ligaments and tendons, but is not possible directly into bone or cartilage.This may damage the device and result in compromised fixation strength." sample evaluated.
Event or Problem Description
As reported, during laparoscopic inguinal hernia repair procedure on (b)(6) 2021, the bard/davol optifix at device was used to fixate an unknown mesh.It was reported that the tip of the device slightly curved without the surgeon articulating it, and broken fasteners were deployed.The surgeon removed the broken fastener from the patient's body; none of the fasteners used fixated the mesh.The device was dry fired outside the patient's body and released broken fasteners.As reported the surgeon was fixating around cooper's ligament when the issue presented.As reported, another bard/davol optifix at device was used to complete the case without any issues.The surgeon is an experienced user of the device.There was no reported patient injury.

• Brand Name: OPTIFIX AT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12231567
• Report Number: 1213643-2021-20198
• Device Sequence Number: 3036438
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 0113330
• Device Lot Number: HUFP1792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other